Catalog +7 (499) Kits for noninvasive prenatal testing

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1 +7 (499) Catalog Kits for noninvasive prenatal testing Kits for identification of the mutations associated with targeted therapy response or resistance Kits for cancer testing Kits for Nucleic acids isolation Design reagent kits for detection of all known genes, polymorphisms and mutations Services in the field of biology and genetic engineering Consumables and reagents supply for molecular genetic researches

2 TestGene s products catalog 1 // 25 Table of contents Company profile 2 Achievements 3 Kits for noninvasive prenatal testing 5 Kits for identification of the mutations associated with targeted therapy response or resistance 9 Kits for cancer testing 13 Kits for Nucleic acids isolation 17 Designing reagent kits for detection of any known gene, polymorphisms and mutations 21 Services in the field of biology and genetic engineering 23 Consumables and reagents supply for molecular genetic researches 23

3 2 // 25 TestGene s products catalog Company profile «TestGene» develops and manufactures kits for molecular genetics. Products are intended for use in research, practical medicine, and in the fields of molecular biology. The focus area non-invasive genetic testing in obstetrics and oncology. The company has its own production laboratory with the necessary equipment for manufacturing and quality assurance of kits based on «real time PCR». The company team of internationally recognized researchers constantly improves the products according to the latest scientific achievements. Certificate ISO 9001:2008 issued by Bureau Veritas Certification Holding SAS (UK Branch) confirms that the Management System of TestGene has been audited and found to be in accordance with the requirements of that management system standard.

4 TestGene s products catalog 3 // 25 Achievements Gold Prize at the Seoul International Innovations Fair TestGene is the best of 663 inventions from 31 countries Taiwan Invention Association recognized Test-RHD as outstanding invention Eurasian patent for a «kit of oligonucleotide primers and probes, and a method for fetus RhD- status detection using ccfdna from Rhnegative pregnant women blood» OPORA Russia: the first place of Business success 2012 in The best innovative project category The winner of the Russian Youth Prize in Nanoindustry Quality Assurance of the Molecular- Pathological Detection of KRAS Mutations in Colorectal Carcinomas The first place in the Interactive Competition Import substitution and Rapid development Semifinal Zworykin Award 2012 : the best of 1500 inventions Quality Assurance of the Molecular- Pathological Detection of RAS Mutations (KRAS, NRAS) in metastatic Colorectal Carcinomas

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6 TestGene s products catalog 5 // 25 Kits for noninvasive testing using pregnant woman blood Detection of cell-free fetal DNA in maternal plasma since 10th week of pregnancy: Simply Easy for use Sensitivity 99% Specificity 99% Minimal invasive Test-RHD kit for noninvasive fetal RHD gene detection since 10th (embryological) week of pregnancy. Benefit: timely and reasonable measures to prevent RhD conflict save 35% of government budget economy for pregnant woman Awareness of fetal RhD status allows obstetrician-gynecologist to provide Rhesus-negative pregnant woman with necessary treatment. Test-RHD is the safest way to detect fetal RHD-status, because it is based on pregnant woman blood testing.

7 6 // 25 TestGene s products catalog Test-SRY is a kit for noninvasive fetal gender testing since 10th (embryological) week of pregnancy using maternal blood. The testing has a particular importance for families with the sex-linked diseases risk. In 1997, Lo et al. discovered that cell-free fetal DNA is present in the plasma and serum of pregnant women (Lo YMD, Corbetta N, Chamberlain PF, Rai V, Sargent IL, Redman CWG, Wainscoat JS. Presence of fetal DNA in maternal plasma and serum. Lancet1997;350: ). The kits for noninvasive testing produced by TestGene are based on real-time PCR technique. The novel approach improves the sensitivity and allows to detect even single DNA copies in maternal blood. To achieve it, ultra-short probes, unique primers and high processive hot-start polymerases are used. In «plus» kits we use a buffer with polymerase that makes workflow more comfortable and reliable. For analysis preparation it is necessary to add 4 mcl of PCR buffer + 4 mcl of primer mix and 12 mcl of DNA. When «classic» kits are using, it is necessary to add 0.2 mcl of polymerase per each tube. Cat. No Description Tests quantity RHD50 Kit for fetal RHD gene identification in maternal blood Test-RHD for 50 tests 50 RHD100 Kit for fetal RHD gene identification in maternal blood Test-RHD for 100 tests 100 RHD50+ Kit for fetal RHD gene identification in maternal blood Test-RHD plus for 50 tests 50 RHD100+ Kit for fetal RHD gene identification in maternal blood Test-RHD plus for 100 tests 100 SRY50 Kit for fetal SRY gene identification in maternal blood Test-SRY for 50 tests 50 SRY100 Kit for fetal SRY gene identification in maternal blood Test-SRY for 100 tests 100 SRY50+ Kit for fetal SRY gene identification in maternal blood Test-SRY plus for 50 tests 50 SRY100+ Kit for fetal SRY gene identification in maternal blood Test-SRY plus for 100 tests 100

8 TestGene s products catalog 7 // 25 THE KITS CHARACTERISTICS Characteristic Test-RHD Test-SRY Comments The earliest gestational age for testing 10th week 7th week It is recommended to use both kits since 10th week of pregnancy in order to avoid wrong results The analytical sensitivity 50 copies per 1 ml of test material (plasma) or 5 copies per 1 reaction (tube) While using the recommended method of DNA isolation Number of exons 3 1 (repeat 3 times) It is necessary in individual case when the level of fetal DNA concentration is too low Control for circulating DNA extraction Available, GAPDH gene (it is always present in human plasma) Absence of the control creates risk of false-negative results (there is no guarantee that the amount of DNA isolated is sufficient for testing) The kit format The mixture is not dispensed It allows to create a comfortable position of the tubes in the device; allows to use both rotary and flatbed types of thermocyclers The performance format The testing equipment Shelf life Monoplex Any real-time PCR thermocyclers 12 months Improved sensitivity of the kits Storage conditions Below -20 C Amount of tests in the kit Amount of reactions in the kit Time of analysis For 50 or 100 patients (plus 20% as reserve) 240 (kit for 100 patients) or 120 (kit for 50 patients) Less than 2 hours There are 50 or 100 tests even in case of single performances If a few of patients are tested at a time, additional saving of reagents is achieved

9 8 // 25 TestGene s products catalog

10 TestGene s products catalog 9 // 25 Kits for identification of the mutations associated with targeted therapy response or resistance TestGene s kits for mutation in EGFR&KRAS genes detection serve 50% of all such tests implemented in Russia. Those kits have successfully passed prequalification in European Molecular Genetics Quality Network (EGFR) and Pathologisches Institut (KRAS). Quality control was carried out on the basis of molecular diagnostic laboratory Republican Clinical Oncology Center of the Ministry of Health Care of the Republic of Tatarstan. It is extremely important to detect mutation status of EGFR and KRAS while selecting a medication to be sure that patients are treated in accordance with the molecular features of the disease. The kits are completely free of other approaches disadvantages, such as: the need for quantitative calibration of the DNA sample, the presence of non-specific signal in the absence of mutation, subjectivity analysis of results, false positive results in cases of excess of the recommended amounts of test material. The type of Taqman technology used in the kits (based on destructible oligonucleotide probes with chemical modifications of locked nucleic acids) has a high sensitivity and specificity. Depending on the total amount of DNA in the sample, there is up to 1% of mutant against a background of wild DNA determined with an accuracy of at least 99,9%. The features of the kits allow to detect reproducibly mutations presented even in low concentration and to minimize the probability of false-negative results. The kits are compatible with all common real-time PCR thermocyclers: ABI7300/7500/StepOne, Bio-Rad iq5/cfx, Rotor-Gene 3000/6000, DТ-prime and etc.

11 10 // 25 TestGene s products catalog THE KITS CHARACTERISTICS Compliant instruments Analytical sensitivity ABI7300/7500/StepOne, Bio- Rad iq5/cfx, Rotor-Gene 3000/6000, DТ-prime and etc 50 copies of mutant DNA Amount of test in the kit per mutation 50 or 100 Number of patients at single PCR-performing 12 or 24 Possible number of patients at one PCR-performing 47 or 93 Necessity for duplicate performing Necessity for samples dilution before analysis False-positive reaction in case of high concentration DNA Reaction time performance Tutorial Support at all stages No necessity No necessity No Approximately 90 hours Mandatory condition. It is carried out on the base of reference laboratory placed in Volga region; specialist s visit for on-site training is also possible Available Major features: A wide range of working concentrations of DNA (from 0,5 ng to ng per reaction) Analysis is implemented at single-performing of PCR Reaction is performed in a single tube (for each mutation) Presence of internal control for reaction High analytical sensitivity A simple results interpretation

12 TestGene s products catalog 11 // 25 The kits allow to implement detection directly from tumor tissue of biopsied material. Version of kits for circulating tumor DNA detection allows to perform testing of patient s plasma or serum. International double-blind clinical trials have shown a high concordance of patient s results derived from tissue and plasma using TestGene s reagents. THE KITS CHARACTERISTICS EGFR-Plasma-12 Reagent kit for mutations and deletions detection in EGFR gene based on real-time PCR 12 EGFR-Plasma-24 Reagent kit for mutations and deletions detection in EGFR gene based on real-time PCR 24 THE KITS FOR TUMOR TISSUE EGFR-12 Kit for mutations and deletion detection in EGFR gene based on real-time PCR 12 EGFR-24 KRAS-12 Kit for mutations and deletion detection in EGFR gene based on real-time PCR Kit for mutations and deletion detection in KRAS gene based on real-time PCR KRAS-24 Kit for mutations and deletion detection in KRAS gene based on real-time PCR 24 BRAF-12 Kit for mutations and deletion detection in BRAF gene based on real-time PCR 12 BRAF-24 Kit for mutations and deletion detection in BRAF gene based on real-time PCR 24

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14 TestGene s products catalog 13 // 25 Kits for cancer testing Prosta-test is designed for noninvasive prostate cancer diagnostics by determinants of PCA3 gene expression level by reverse transcription followed by quantitative polymerase chain reaction (PCR). Material for PCR human RNA samples derived from fresh or fixed in the medium in order to stabilize and preserve urine RNA obtained after digital rectal examination (DRE) of the prostate, thus achieving noninvasiveness. Prostate cancer takes 3-4 place in the world s structure of malignant neoplasms (more than 600 thousand cases in a year). In the USA it takes the 1st place of morbidity more than 200 thousand patients per a year. In Europe it takes 1-2 places (more than 200 thousands of patients per a year). PROSTA-TEST PERFORMING INCLUDES THE FOLLOWING STEPS Taking an urine sample Sample preparation and Reverse transcriptase Interpretation of the after DRE RNA extraction PCR amplification results and calculation of PCA3 expression level

15 14 // 25 TestGene s products catalog The result of Prosta-test expressed quantitatively indicates the risk of prostate cancer presence and may serve as an additional criterion for the first or subsequent biopsy appointment along with the measurement of the PSA level in the blood, ultrasonography (TRUS), MRI, CT and digital rectal examination (DRE). ANALYTICAL FEATURES Analytical specificity 100 % Analytical sensitivity Range of total RNA quantity required for test performance 100 RNA copies Min 0,5 mcg, max 5 mcg Value of PCA3 level considered as normal < 35 THE KITS FOR TUMOR TISSUE PCA3-12 Kit for detection of PCA3-gene expression in urine Prosta-test 12 PCA3-24 Kit for detection of PCA3-gene expression in urine Prosta-test 24

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18 TestGene s products catalog 17 // 25 Kits for Nucleic acids isolation The sample preparation is crucial for obtaining correct results of PCR analysis. That is why it is very important to use proven and reliable reagents for nucleic acid extraction. Only optimal concentration and high quality of nucleic acids allow to unlock 100% of any PCR methods potential. TestGene LLC produces kits for DNA isolation based on two methods: silica-based columns magnetic method based on magnetic microbeads The kits reduce time of DNA isolation it is convenient for professionals and patients. The kits do not require purchase of additional equipment it is convenient for organization. DNA-PLASMA The kit for circulating DNA isolation from plasma. It is intended for use in prenatal noninvasive testing and in oncology. DNA-plasma DNA isolation from 1 ml ( DNA-plasma-1 ) and from 2 ml ( DNA-plasma-2 ) of blood plasma. DNA-tissue DNA isolation from formalin-fixed and paraffin-embedded tissues. DNA-blood kit for total DNA isolation and purification from whole blood, serum, leukocytes, lymphocytes, buccal epithelium, cell cultures, smears. The DNA isolated is suitable for HLA-typing, detecting of polymorphisms and mutations in the genome by PCR, sequencing, mass spectrometry. DNA plasma-m kit for circulating DNA isolation from plasma. Absence of necessity for centrifugation allows to implement DNA isolation within 30 minutes.

19 18 // 25 TestGene s products catalog COMPARATIVE CHARACTERISTICS OF TESTGENE S KITS FOR DNA ISOLATION Characteristic DNA-plasma-1 DNA-plasma-2 DNA-plasma-M new Method of operation Spin columns Spin columns Magnetic beads Volume of plasma required for reliable testing of fetal gender and RhD-status since 10th week of pregnancy 1 ml of plasma (use only after 20th week of pregnancy) 2 ml of plasma 1 ml of plasma The earliest gestational age for obtaining significant amount of fetal DNA 20 week of pregnancy 10 week of pregnancy 7 week of pregnancy Testing time 50 minutes 50 minutes 40 minutes Amount of isolated DNA 1-3 ng/mcl 1-3 ng/mcl 3-5 ng/mcl Purity of isolated DNA (ratio 260/280 nm) 1,7-1,8 1,7-1,8 1,7-1,9 Necessary equipment High-speed centrifuge High-speed centrifuge Magnet for tubes The ability of integration into a robotics station The ability to increase the started amount of biomaterial No No Yes No No Yes (up to 50 ml of plasma) Contamination risk Medium Medium Low

20 TestGene s products catalog 19 // 25 ORDER LIST DNA-P2-50 DNA-P2-100 DNA-P1-50 DNA-P1-100 Kit for DNA isolation from 2 ml of blood plasma DNA-plasma-2 Kit for DNA isolation from 2 ml of blood plasma DNA-plasma-2 Kit for DNA isolation from 2 ml of blood plasma DNA-plasma-1 Kit for DNA isolation from 2 ml of blood plasma DNA-plasma DNA-T-50 Kit for DNA isolation from fixed tissues DNA-tissue 50 DNA-T-100 Kit for DNA isolation from fixed tissues DNA-tissue 100 DNA-B-50 Kit for DNA isolation from blood DNA-blood 50 DNA-B-100 Kit for DNA isolation from blood DNA-blood 100 DNA-PM-50 Magnetic kit for DNA isolation from 1 ml of blood plasma DNA-plasma-М1 50

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22 TestGene s products catalog 21 // 25 Designing reagent kits for detection of any known gene, polymorphisms and mutations TestGene LLC develops kits for molecular genetic researches in the field of monogenic and multifactorial genetic disorders, oncology and prenatal testing based on the common reliable techniques: PCR real-time PCR and sequencing TestGene LLC has developed analogs for such internationally well-known kits as TaqMan SNP Genotyping Assays produced by Applied Biosystems (Endpoint Fluorescence Detection) and its own test systems (electrophoretic detection and method of fluorescence detection during allele-specific amplification) for real time cyclers, such as the ABI 7300, ABI 7500, Bio-Rad icycler, RotorGene 3000/6000 and / or agarose / polyacrylamide gels. Every kit is intended for 600 PCR reactions (analysis of 400 DNA samples taking into account the negative controls and PCR performing checkup. Technique: There is fluorescent detection method based on decomposable oligonucleotide probes with use of synthetic oligonucleotide analogues, used for polymorphic markers detection. PCR is performing with use of able for freezing ready-made mixture containing dntps, Mg2 + and reaction buffer with the primers and probes. DNA polymerase is using for Hot Start PCR. Genomic human DNA extracted from saliva, blood or other biological material, is used for testing.

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24 TestGene s products catalog 23 // 25 Services in the field of biology and genetic engineering Genotyping of patient s samples (SNP testing) Mutation detection Measurement of heteroplasmy level Gene expression measurement DNA sequencing services Identification of translocations, deletions, insertions and duplications Determination of the promoter region methylation status Designing and validation of test-systems for mutations detection Other services in the field of molecular biology Consumables and reagents supply for molecular genetic researches For molecular biology: Primers Probes Enzymes (polymerases, etc.)

25 24 // 25 TestGene s products catalog

26 +7 (499) TestGene LLC 9 44th Inzhenerny proyezd, Ulyanovsk, Russia, info@testgen.ru Website: Technical support: support@testgen.ru

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